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Pharmacyclics Reports Recent Developments From Clinical Studies of its Btk Inhibitor PCI-32765
Date:6/6/2011

this study were presented today at the 2011 Annual Meeting of ASCO and the full ASCO presentation is posted on our website.

Two ongoing studies, initiated in Q1 2011, are evaluating PCI-32765 in combination with standard therapies for CLL/SLL. We have enrolled 34 patients in these studies and anticipate completing enrollment in 2011.

From these studies, we expect to be able to analyze initial 3-month safety data for ofatumumab/PCI-32765 and bendamustine/rituximab/PCI-32765 in the second half of 2011. To date the preliminary safety data from these combination studies suggests that these combinations are likely to be safe.

Based on the significant single-agent activity in CLL/SLL from the ongoing Phase IB/II trial, and contingent upon confirmation of 3-month combination safety data, Phase III planning is currently underway. We expect to initiate a Phase III study in CLL/ SLL in the first half of 2012.  

-- Mantle Cell Lymphoma (MCL)
A Phase II study of single-agent PCI-32765 in relapsed or refractory MCL (PCYC-1104) began enrolling patients in late February 2011. To date, we have enrolled 30 patients on this trial and anticipate completing enrollment by the end of calendar 2011. Initial review of early data from this ongoing study suggests that the high overall response rate observed in Phase I is likely to be similar in Phase II. We anticipate submitting an abstract with interim results for presentation at the 2011 American Society of Hematology (ASH) Meeting. Contingent upon the ongoing analysis of PCYC-1104, we will soon begin Phase III planning in MCL. We anticipate that a Phase III study will be initiated in 2012.

-- Diffuse Large B-Cell Lymphoma (DLBCL)
A multicenter, open-label, Phase II study of PCI-32765 in patients with relapsed or refractory DLBCL (PCYC-1106) began enrollment in May 2011. This study is designed to assess the activity of PCI-32765 in two genetically distinct subt
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